Atrial FibrillationpeQasusNCT05710822
QDOT Based PVI for Atrial Fibrillation Treatment - The peQasus Study
An observational study of Atrial Fibrillation, run by University of Luebeck.
Trial summary
PeQasus is a worldwide, retrospective, multicenter analysis focusing on QDOT based PVI. Data of at least 300 patients with QDOT based PVI will be collected. All data will be evaluated after anonymization. Primary endoints are efficacy and safety. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- pulmonary vein isolation
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2023to 30 Jun 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Afib patients with indication to pulmonary vein isolation
Who may be able to join
- Suitable for PVI
Who cannot join
- Non suitable for PVI
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Very High-Power Short-duration Ablation Utilizing the QDOT Micro Ablation Catheter for Pulmonary Vein Isolation - A Multicenter Study.
PeQasus is a worldwide, retrospective, multicenter analysis focusing on QDOT based PVI. Data of at least 300 patients with QDOT based PVI will be collected. All data will be evaluated after anonymization. Primary endoints are efficacy and safety.
- Conditions
- Atrial Fibrillation
- Being tested
- pulmonary vein isolation
- Keywords
- Catheter abaltion, very high-power short-duration, QDOT
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary vein isolationDevice
pulmonary vein isolation utilizing the QDOT Micro ablation catheter
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the procedure
Acute PVI
Measured: Periprocedural
Saftey (Cardiac tamponade)
Periprocedural complications (occurence of cardiac tamponade)
Measured: Periprocedural
Safety (Stroke)
Periprocedural complications (occurence of stroke)
Measured: Periprocedural
Safety (Bleeding)
Periprocedural complications (occurence of puncture site bleeding)
Measured: Periprocedural
Secondary outcomes (4)
Procedure time
Measured: Periprocedural
LA dwelling time
Measured: Periprocedural
First pass isolation
Measured: Periprocedural
12 months follow-up
Occurence of aftrial fibrillation or atrial tachycardia >30 Seconds between 91 days and 12 months of follow-up
Measured: 91 days - 12 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start31 Jan 2023 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian-H. Heeger, MD, University of Luebeck
- Investigators
- Christian-Hendrik Heeger, MD, Principal investigator, Department of Rhythmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710822
- Sponsor's protocol ID
- peQasus study
- Acronym
- peQasus
- Status last verified
- Jan 2023
- First submitted
- 17 Jan 2023
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Very High-Power Short-duration Ablation Utilizing the QDOT Micro Ablation Catheter for Pulmonary Vein Isolation - A Multicenter Study.
- ClinicalTrials.gov ID
- NCT05710822
- Acronym / sponsor ID
- peQasus / peQasus study
- Conditions
- Atrial Fibrillation
- Keywords
- Catheter abaltion, very high-power short-duration, QDOT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- 31 Jan 2023 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PeQasus is a worldwide, retrospective, multicenter analysis focusing on QDOT based PVI. Data of at least 300 patients with QDOT based PVI will be collected. All data will be evaluated after anonymization. Primary endoints are efficacy and safety.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Afib patients with indication to pulmonary vein isolation
Key inclusion criteria (1 listed)
- Suitable for PVI
Key exclusion criteria (1 listed)
- Non suitable for PVI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulmonary vein isolationpulmonary vein isolation utilizing the QDOT Micro ablation catheter | Device | – |
Primary outcome
Efficacy of the procedure
Time frame: Periprocedural
Acute PVI
Saftey (Cardiac tamponade)
Time frame: Periprocedural
Periprocedural complications (occurence of cardiac tamponade)
Safety (Stroke)
Time frame: Periprocedural
Periprocedural complications (occurence of stroke)
Safety (Bleeding)
Time frame: Periprocedural
Periprocedural complications (occurence of puncture site bleeding)
4 secondary outcomes
Procedure time
Time frame: Periprocedural
LA dwelling time
Time frame: Periprocedural
First pass isolation
Time frame: Periprocedural
12 months follow-up
Time frame: 91 days - 12 months after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian-Hendrik Heeger, MD principal investigator
Department of Rhythmology
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University of Luebeck.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian-Hendrik Heeger, MD (004945150075293, christian.heeger@gmx.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the procedure (time frame: Periprocedural). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.